ACCL1333

A study designed to evaluate the safety and efficacy of Apixaban for Thromboembolism Prevention versus No Systemic Anticoagulant Prophylaxis during Induction Chemotherapy in children with newly diagnosed Acute Lympho.

Type: Treatment

Principal Investigator: Richard Drachtman, MD

Trial is open for enrollment

• Rutgers Robert Wood Johnson Medical School
• Robert Wood Johnson University Hospital

ALIGN-AR

To evaluate the safety and effectiveness/performance of the Transfemoral JenaValve Pericardial TAVR System in the treatment of patients with symptomatic severe aortic regurgitation.

Type: Device trial

Principal Investigator: Mark Russo, MD

Trial is open for enrollment

• Rutgers Robert Wood Johnson Medical School
• Robert Wood Johnson University Hospital

ALLIANCE

To establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

Type: Device Trial

Principal Investigator: Mark Russo, MD

Trial is open for enrollment

• Rutgers Robert Wood Johnson Medical School
• Robert Wood Johnson University Hospital

ALLIANCE VIV

To establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing aortic bioprosthetic valve.

Type: Device Trial

Principal Investigator: Mark Russo, MD

Trial is open for enrollment

• Rutgers Robert Wood Johnson Medical School
• Robert Wood Johnson University Hospital

Assessing the Normal Microbiome and Virome of the Lung: A Pilot Study

Trial is open for enrollment.

• Cooperman Barnabas Medical Center

ATRIUM

AbatacepT foR ImmUne checkpoint inhibitor associated Myocarditis (ATRIUM): A Phase 3, Investigator-Initiated, Randomized, DoubleBlind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Compared to Placebo in Hospitalized Participants with Immune Checkpoint Inhibitor Associated Myocarditis

To qualify, participants must:

• Be of 18 years and older
• Recent use of an FDA-approved immune checkpoint inhibitor alone or in combination with other cancer therapies (i.e., chemotherapy, radiation therapy or targeted therapy)
• A diagnosis of myocarditis
• Must be hospitalized at the time of randomization
• On 1000 mg of solumedrol per day for myocarditis or with an intent to initiate 1000 mg of solumedrol per day for myocarditis within 24 hours of first administration of study drug
• Serum evidence of ongoing myocardial injury

Principal Investigator: Dr. Sasha East

Study Sponsor:Massachusetts General Hospital

Trial is open for enrollment

For inquiries, call (732) 867-1550 or email: cardiologyclinicaltrials@rwjms.rutgers.edu

• Rutgers Robert Wood Johnson Medical School
• Robert Wood Johnson University Hospital

Biofourmis

Artificial Intelligence Mobile Health Trial of A Digital Platform To Optimize GDMT Using Wearable Sensors

Guideline directed medical treatment (GDMT) has shown to improve outcomes in patients with heart failure with reduced ejection fraction (HFrEF). The Division of Cardiovascular Disease and Hypertension is seeking patients with HFrEF for a multicenter, randomized, outpatient study to evaluate the effectiveness of the cloud based BiovitalsHF™ technology. The study provides a remote wireless vital collection device and involves wearing a wearable sensor (Everion®) on the arm that will be remotely monitored for 90 days. The BiovitalsHF™ platform integrates data collected remotely from the vital collection device and the wearable sensor to manage the initiation and titration of GDMT outside of traditional clinical encounters.

To qualify, participants must:

• Be at least 22 years old
• Have been diagnosed with heart failure for at least 3 months
• Have an ejection fraction less than or equal to 40%

This study offers Continuous vital signs trends, Remote medication management and Care coordination

Principal Investigator: Dr. Partho P. Sengupta

Study Sponsor: Biofourmis Inc. (www.biofourmis.com)

Trial is closed for enrollment

For inquiries, call (732) 867-1550 or email: cardiologyclinicaltrials@rwjms.rutgers.edu

• Rutgers Robert Wood Johnson Medical School
• Robert Wood Johnson University Hospital

BiSpectral Index (BIS) Monitoring and Sedation Practices in Critically Ill Mechanically Ventilated Patients: A Single Center, Prospective, Randomized Control Trial

Trial is open for enrollment

• Cooperman Barnabas Medical Center

CLASP II TR

A study designed to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation.

Principal Investigator: Mark Russo, MD

Type: Device Trial

This trial is open for enrollment

• Rutgers Robert Wood Johnson Medical School
• Robert Wood Johnson University Hospital

CLASP IID & IIF

Evaluation of the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Type: Device trial

Principal Investigator: Mark Russo, MD

Trial is open for enrollment

• Rutgers Robert Wood Johnson Medical School
• Robert Wood Johnson University Hospital

CORCINCH-HF

To evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).

Type: Device Trial

Principal Investigator: Mark Russo, MD

Trial coming soon

• Rutgers Robert Wood Johnson Medical School
• Robert Wood Johnson University Hospital

Effect of GBT440 in Pediatrics With Sickle Cell Disease

A study designed to evaluate the pharmacokinetics, safety, tolerability, and exploratory treatment effect of GBT440 in adolescents with Sickle Cell Disease.

Type: Treatment

Principal Investigator: Richard Drachtman, MD

Trial is open for enrollment

• Rutgers Robert Wood Johnson Medical School
• Robert Wood Johnson University Hospital